Thursday, March 04, 2010

A study published in a recent issue of the Annals of Internal Medicine finds that even with continuous use of the nicotine patch for six months, very few smokers were able to stay off cigarettes long-term. In fact, the rates of long-term abstinence with the nicotine patch were far lower than even the lower end of unaided long-term quit rates. The research demonstrates that nicotine replacement therapy is terribly ineffective in achieving smoking cessation, is less effective than unaided quitting, and is probably a waste of time and money on a population basis.

Previous research has shown that unaided quit attempts yield one-year continuous abstinence rates of between 3% and 11%. Gritz et al. found that in high-motivation situations, such as the Great American Smokeout or New Year's Day resolutions, unaided quitting yielded a one-year continuous abstinence rate of 11%. Nevertheless, a generally accepted value for long-term one-year abstinence with unaided quitting is somewhere around 3% or 5%.

So, with that as a background, take a guess as to how many of the 568 subjects in the study of nicotine patch therapy were able to achieve continuous one-year abstinence (half of these subjects used the patch for 2 months and half used it for 6 months).

... None of the above. The actual number of subjects who achieved one-year continuous abstinence with the nicotine patch was 5, or only 0.8% of the sample.

Even assuming that unaided quit attempts yield a long-term continuous abstinence rate of only 3%, use of the nicotine patch did not even come close to achieving a 3% long-term continuous success rate.

Interestingly, despite these results, the paper concludes that extended-therapy nicotine patch therapy is effective. In fact, it only mentions the 0.8% long-term success rate in fine print in the results section, ignoring this critical result in the abstract and discussion section.

Even the point-prevalence abstinence rate at one year with extended-therapy nicotine patch use was a dismal 14.5%, and was no better than the point-prevalence abstinence rate at one year with short-term nicotine patch therapy (14.3%), calling into question the paper's odd conclusion that extended-use nicotine patch therapy is effective.

The Rest of the Story

This study adds to the growing body of research that pharmaceutical treatment of smoking dependence is a dismal intervention and that unaided quitting is more effective than the use of nicotine replacement therapy or other drug approaches. Nicotine replacement therapy has no business being the mainstay of the nation's strategy for smoking cessation.

In light of these findings, one might ask the question of how the paper could possibly conclude that long-term nicotine patch therapy is effective and why it buries its own finding that only 5 of the 568 subjects achieved long-term continuous abstinence.

We can't be sure, but I can tell you for sure that one of the following statements is true. Your role is to figure out which one it is. The choices are:

A. A rate of 0.8% for long-term continuous abstinence is actually very high. If 8 out of 1000 patients quits long-term, that is the sign of a very effective medical treatment.

B. A rate of 0.8% for long-term continuous abstinence is actually very high because long-term quit rates for unaided quit attempts are only about 0.2%.

C. These quit rates are artificially low because people who enter into clinical trials on smoking cessation are a highly unmotivated group.

D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The answer is ...

... D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The almost laughable irony is that the major anti-smoking groups are calling on electronic cigarettes to be pulled off the market and banned because they are concerned that the long-term success rates of these products may not be very high and they would rather that smokers stick with the "proven" nicotine replacement therapy drugs. But the rest of the story is that of 568 patients treated with these "proven" nicotine replacement drugs, only five achieved long-term continuous abstinence, far fewer than would have been expected with unaided cessation.

The not so laughable irony is that every one of the anti-smoking groups which has called for electronic cigarettes to be pulled off the market because their effectiveness has not been shown to be as "great" as nicotine replacement therapy has a financial conflict of interest with pharmaceutical companies that manufacture the smoking cessation drugs.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.